Kornimate/medical-research-clean huggingface dataset:
safety and effect of sanguinate™ infusion in patients at risk of delayed cerebral ischemia (dci) following subarachnoid hemorrhage (sah)

Conditions: Cerebral Ischemia

Summary: safety and effect of sanguinate on patients dci following sah.

the purpose of this study is to study the safety and effect of sanguinate on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.

Eligibility criteria:
inclusion criteria: * signed and dated written informed consent by the subject or his/her legally authorized representative; * modified rankin (mrankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage; * ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and * hunt and hess (h\&h) grade 3 or 4, or world federation of neurological surgeons (wfns) score 3 or 4 prior to the procedure, and modified fisher (mfisher) grade 3 or 4, prior to the procedure; or * clinical signs of ("symptomatic") delayed cerebral ischemia; or * angiographic evidence of cerebral vasospasm exclusion criteria: * in the judgment of the investigator the patient is not a good candidate for the study * evidence of rebleed following the procedure * subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation * diagnosed moderate to severe pulmonary hypertension * radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion) * history within the past 6 months and/or finding of decompensated heart failure * acute myocardial infarction within 3 months prior to the administration of the study drug * left ventricular ejection fraction \<40%, as determined by prior echocardiography or clinical signs of chf * medical history or concurrent evidence of moderate to severe renal insufficiency (estimated creatinine clearance \< 30 ml/min)

Keywords: dci delayed cerebral ischemia sah subarachnoid hemorrhage aneurysmal subarachnoid hemorrhage cerebral ischemia brain ischemia
lower body positive pressure treadmill training in post-stroke gait impairment

Conditions: Gait, Hemiplegic

Summary: lower body positive pressure (lbpp) decreases weight bearing and ground reaction forces, with potentially positive effects on qualitative gait indices. however, which gait features are shaped by lbpp gait training in post-stroke patients is still poorly predictable. a pilot study on the effects of lbpp gait training on qualitative and quantitative gait indices in patients with hemiparesis due to stroke in the chronic phase was carried out. twenty-five patients who suffered from a first, single, ischemic, supra-tentorial stroke occurred at least 6 months before study inclusion were provided with 24 daily sessions of lbpp treadmill gait training using alterg device. these patients were compared with 25 age-matched healthy controls (hc), who were formerly provided with the same amount of alterg training, and 25 patients with the same clinical-demographic characteristics of the first group of patients, who previously underwent conventional treadmill gait training (tgt). qualitative and quantitative gait features, including functional ambulation categories, gait cycle features, and muscle activation patterns were analyzed before and after the training (alterg or tgt).


Eligibility criteria:
inclusion criteria: * age ≥ 55 years; * first, single, ischemic supra-tentorial stroke occurred at least 6 months before the study inclusion; * a functional ambulatory categories (fac) score of \>2; * ability to control head and trunk posture; * no systemic or cardiovascular contraindication to lbpp exclusion criteria: • medical and/or psychiatric illness potentially interfering with the treatment.
registry of secondary revascularization

Conditions: Coronary Artery Disease Progression; Coronary Artery Disease of Significant Bypass Graft; Stent Stenosis; Stent Restenosis; Coronary Arteriosclerosis

Summary: the study will evaluate patients with, at least, one previous procedure of coronary revascularization (surgical, percutaneous or both), that are referred for a new, clinically indicated, diagnostic coronary angiography, to describe their clinical characteristics, management, and prognosis, and will propose a prognosis-oriented classification.

secondary or repeated revascularization refers to any repeated coronary intervention following an index coronary revascularization procedure, and represents a wide proportion of patients received in catheterization laboratories. these patients have an increased complexity and worse outcomes than patients without previous revascularization. clinical investigation has focused in lesion-specific treatments when a single previous revascularization fails, but there is paucity of patient-level information including complex patients with multiple revascularizations. other gaps in evidence addressed by this study are the absence of a a prognosis-oriented classification of previously revascularized patients and a clinical meaningful definition of revascularization failure. the registry as well intends to provide insights on how secondary revascularization decisions are taken and long term prognosis after secondary revascularization. the registry of secondary revascularization (in spanish: registro multicéntrico de revascularización secundaria, revasec) is a multicenter, prospective, observational cohort study that incudes consecutive patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography, in different spanish hospitals. the aims are describing the incidence, clinical profile, therapeutic management and prognosis of these patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * previous successful coronary revascularization, either percutaneous or surgical, in at least one vessel with diameter ≥2 mm * previous successful coronary revascularization must have been successful in at least one vessel and the patient must have been discharged after the previous revascularization * clinically indicated diagnostic coronary angiography * provide written informed consent exclusion criteria: * inability or refusal to provide written informed consent * patient included in any other clinical trial in which the revascularization device is blind to patient or investigator, or is not commercially available * insufficient data about previous revascularizations * previous revascularization only on vessels of less than 2 mm or which was not successful in any vessel * previous percutaneous revascularization with simple plain old balloon angioplasty * index coronary angiography indicated as scheduled repeated angiography, planned percutaneous coronary intervention, or pre-surgical angiography

Keywords: secondary revascularization repeat revascularization coronary revascularization coronary artery bypass graft
the effect of semi-quantitative procalcitonin assay to the adequacy of empirical antibiotics and mortality in septic patients

Conditions: Sepsis

Summary: sepsis is a serious clinical condition with a considerable morbidity and mortality. procalcitonin (pct) is a good biomarker for early diagnosis and infection monitoring. the present study aimed to investigate the effect of semi-quantitative pct test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients. the hypothesis of the study are : * there is an effect on mortality between septic patients who do and do not do semi-quantitative pct examination * there is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative pct examination * there is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative pct examination study design is randomized diagnostic trial which is also a pragmatic trial.


Eligibility criteria:
inclusion criteria: * aged more than 18 years old * have at least two concomitant systemic inflammatory response syndrome criteria * have focal infection * with or without sign of organ hypoperfusion or dysfunction exclusion criteria: * post operative patient * trauma patient * have obtained prior antibiotic * refused to participate

Keywords: semiquantitative procalcitonin sepsis antibiotics mortality
effects of food on the bioavailability and pharmacokinetic profile of itasetron after a single oral dose in healthy male subjects

Conditions: Healthy

Summary: food interaction, pharmacokinetics, safety and tolerability


Eligibility criteria:
inclusion criteria: * all participants in the study will range from 21 to 50 years of age and be within +- 20% of their normal weight (broca-index) * written informed consent in accordance with good clinical practica and local legislation exclusion criteria: * subjects will be excluded from the study if the results of the medical examination or laboratory tests are judged by the investigator to differ significantly from normal clinical values * subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders * subjects with known history of orthostatic hypotension, fainting spells or blackouts * subjects with chronic or relevant acute infections * subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * subjects who have taken a drug with a long half-life (\>= 24 hours) within one month before enrolment in the study * subjects who received any other drugs which might influence the results of the trial during the week previous the start of the study * subjects who have participated in another study with an investigational drug within the last 2 months preceding this study * subjects who are unable to refrain from smoking on study days * subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day * subjects who drink more than 60 g of alcohol per day * subjects who are dependent on drugs * subjects who have donated blood (\>= 100 ml) within the last 4 weeks * subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
the effect of visual video with korotkoff sounds on blood pressure measurement skills and anxiety levels

Conditions: Anxiety

Summary: background: the aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels. methods: this was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. aural and visual video containing korotkoff sounds were shown to the students before the practice.

background: the aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels. methods: this was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. aural and visual video containing korotkoff sounds were shown to the students before the practice. the data of the research were collected with the state-trait anxiety inventory short version (stais-5, stait-5) and the student introduction form.

Eligibility criteria:
inclusion criteria: * studying in the first year of the nursing department in the 2021-2022 academic year, * taking the "pulse and blood pressure measurement" course and laboratory practice * students who agree to participate in the study will be included. exclusion criteria: * previous manual blood pressure measurement experience, * those who do not participate in the theoretical part of the "pulse and blood pressure measurement" course, * students who do not attend the lesson on the day of the applications will not be included.

Keywords: anxiety blood pressure measurement skills korotkoff sounds nursing students
progression rate of pseudoxanthoma elasticum-associated choroidal and retinal degeneration

Conditions: Pseudoxanthoma Elasticum

Summary: this study aims to systematically assess the retest reliability and ability to detect a change of new visual function tests and ophthalmological imaging methods for observing the natural course of pseudoxanthoma elasticum (pxe).


Eligibility criteria:
inclusion criteria: * adult patients with pseudoxanthoma elasticum according to the plomp criteria or adult patients with a pxe-mimicking phenotype (angioid streaks and peau d'orange \[e.g., enpp1 or ggcx-associated disease\]) * best-corrected visual acuity (bcva): ≤1.0 logmar exclusion criteria: * inability to give informed consent * claustrophobia * prior surgery (other than anti-vegf injections, cataract surgery, yag laser capsulotomy, or laser retinopexy) that - according to the investigator's judgment - may affect visual function assessments (e.g., retinal detachment surgery, glaucoma filtration surgery, or a history of a corneal transplant in the study-eye) * concurrent ophthalmic conditions in the study eye that (according to the investigator's judgment) may contribute to loss of vision, such as clinically significant opacification of the ocular media (corneal dystrophies, cataract), other retinal diseases, or disease of the optic nerve head and visual pathway (including amblyopia) * major surgery planned or other events that (according to the investigator's judgment) could hinder follow-up examinations (e.g., knee replacement)
an approved drug to study a new indication for seasonal allergic rhinitis in patients with asthma (0476-269)

Conditions: Rhinitis, Allergic, Seasonal; Asthma, Bronchial

Summary: the purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.

the duration of treatment is 2 weeks.

Eligibility criteria:
inclusion criteria: * non-smoker * a 2-year documented history of seasonal allergic rhinitis * a 1-year documented history of chronic asthma * positive allergy testing exclusion criteria: * medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
clinical evaluation of genex® ds in instrumented posterolateral fusion

Conditions: Degenerative Disc Disease; Spondylolisthesis; Stenosis

Summary: the overall goal of this clinical study is to characterize the fusion rate of genex® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. assessments are made using ap and lateral x-rays, f/e x-rays, and ct scans genex® ds has been cleared by the fda for use in these procedures; however this study will allow more detailed characterization of genex® ds performance in the long-term (1 year). by using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.


Eligibility criteria:
inclusion criteria: * men or women 18-75 years of age * have ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol * have a spinal condition of the lumbar spine (l1-s1) requiring instrumented posterolateral fusion at one or two levels exclusion criteria: * patients undergoing instrumented fusion for trauma, tumor, psuedoarthrosis, or same- - level recurrent stenosis * patients where placing graft material on both sides (posterolateral gutters) is not possible, for example in the case of a complete facetectomy * patients requiring instrumented fusion in the cervical or thoracic spine * extraspinal cause of back pain such as trauma, infection, instrumentation failure, or neoplasm * severe degenerative bone disease * hypercalcemia * active local or systemic infection * morbid obesity defined as bmi \> 40 * patients who are pregnant / able to become pregnant and not following a reliable contraceptive method * uncooperative patients who can't or won't follow post-operative instructions including individuals who abuse drugs or alcohol * anatomy or other factors that prohibit safe surgical access to the surgical site * allergy or sensitivity to any component of the treatment procedure * inadequate tissue coverage over the operative site * inadequate bone stock or bone quality * fever or leukocytosis * uncorrectable coagulopathy or hemorrhagic diathesis * uncontrolled diabetes * severe vascular disease or cardiopulmonary conditions that present prohibitive anesthesia risk * neuromuscular disease or disorder * mental illness * has an active workman's compensation lawsuit
a study of the efficacy and safety of imatinib mesylate in patients with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit gene

Conditions: Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)

Summary: in the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. the 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.


Eligibility criteria:
inclusion criteria: * men and non-pregnant women ≥18 years of age with the histopathologically documented diagnosis of malignant gist that was unresectable and/or metastatic. confirmation of kit (cd117) expression via immunohistochemical analysis of tumor sample was also required * at least one measurable lesion, as defined by southwestern oncology group (swog) solid tumor response criteria, which had not been previously embolized or irradiated * performance status ≤3 as defined by the eastern cooperative oncology group (ecog) criteria, as well as a life expectancy ≥6 months and adequate end organ function defined as follows: total bilirubin \ 1.5 x 10\^9/l, platelet count \>100 x 10\^9/l exclusion criteria: * patients with fewer than five years of disease-free survival from any other (non-gist) malignancy except if the other malignancy was not currently clinically significant and did not require active intervention or if the other malignancy was a basal cell skin cancer or a cervical carcinoma in situ * patients with known brain metastases * evidence of any of the following disorders: grade iii/iv cardiac failure as defined by the new york heart association criteria, severe concomitant disease, acute or known chronic liver disease (i.e. chronic active hepatitis, cirrhosis) or hiv infection * chemotherapy or other investigational therapy within four weeks prior to study entry (six weeks for nitrosourea or mitomycin-c) and/or radiotherapy to ≥25% of the bone marrow * inability to cooperate * major surgery within two weeks or exposure to other investigational agents within 28 days of entry into the study other protocol-defined inclusion / exclusion criteria may have applied.

Keywords: gist c-kit imatinib mesylate
study of aolanti weikang tablets in healthy volunteers

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of aolanti weikang tablets to determine the mtd in healthy volunteers

this is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of aolanti weikang tablets in healthy volunteers. aolanti weikang tablets is a chinese patent drug designed to treat functional dyspepsia (fd). the proposed dose escalaction levels is 3,6 and 8 tablets. if mtd is not established up to 8 tablets, the dose escalaction will be stopped. in each dose level, subjects will be randomly given orally aolanti weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the safety follow up for 14 days. no intrapatient dose-escalation is permitted.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) :≥19 and ≤26 kg/m2 * signed written informed consent exclusion criteria: * with in 7 days of screening, the average number of stool \> 2 times/day * with in 7 days of screening, with the presence of ≥ type 5 stool form per the bristol stool form scale * at least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others) * digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the investigator * smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration * history of drug or aurantium allergy * concomitant medication within 2 weeks prior to drug administration or any drug being used * participated in other clinical trials within 3 months before screening * major surgery/surgical therapy for any cause within 4 weeks of screening, or scheduled surgeries within 2 weeks after the last dose of study drug * subjects not agree to use adequate contraception from study entry through at least 28 days after the last dose of study drug * pregnancy or nursing * other conditions that unsuitable for enrollment considered by investigator